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临床试验/NCT02430987
NCT02430987已完成不适用

Prevalence of Hypoactive Sexual Desire Disorder in Sexually Active Postmenopausal Women With Metabolic Syndrome Women Attending in a Public Hospital Clinic in Brazil: a Cross-sectional Study

Faculdade de Ciências Médicas da Santa Casa de São Paulo2 个研究点 分布在 1 个国家目标入组 291 人开始时间: 2014年9月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
291
试验地点
2
主要终点
application of questionnaire

研究概览

简要总结

Objective: To evaluate the prevalence of hypoactive sexual desire disorder (HSDD) in postmenopausal women diagnosed with metabolic syndrome (MS) and to compare it to that of a control group without MS.

Design: Cross-sectional study. Setting: Two public tertiary hospitals in the state of São Paulo, Brazil. Population: Two-hundred ninety-one postmenopausal women between 40 and 65 years of age.

Methods: Sexual function was evaluated using the Female Sexual Function Index (FSFI) questionnaire and DSM-IV-TR diagnostic criteria and was related to the diagnosis of MS, which was determined according to the guidelines defined by the Adult Treatment Panel (ATP III).

Main outcome measures: Analysis of sexual function with emphasis on sexual desire (HSDD), the presence of MS and its components.

详细描述

Study location Menopause Outpatient Clinic of the School of Medical Sciences of Santa Casa de São Paulo (FCMSCSP) and the 'Leonor Mendes de Barros' Maternity Hospital (HMLMB).

Population From 2015 to 2018, we were invited 1,200 postmenopausal women who regularly visit these institutions to undergo routine climacteric screening. After applying the inclusion and exclusion criteria, 291 sexually actives women were selected and invited to participate in the study. All participants signed an informed consent form.

Design A cross-sectional study was conducted. After the women agreed to participate in the study, they were stratified into 2 groups: group 1 - patients with MS and group 2 - control (without MS); the women in each group had diagnoses of HSDD and FSD. The results for women in group 1 were compared with those for women without MS in group 2.

Main outcome measures

Sexual function was assessed using the Female Sexual Function Index (FSFI) questionnaire,8 validated for the Portuguese language9 with 19 items that measure female sexual function. Cut-off points of > 2310 and > 26.58 were adopted to define the presence of FSD. A score of 5 or less for the sum of items that compose the desire domain of the FSFI questionnaire was used to define the presence of HSDD in postmenopausal women.11 The questions are as follows:

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
Single (Participant)

入排标准

年龄范围
40 Years 至 65 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • The inclusion criteria were as follows:
  • 40-65 years of age;
  • One year of amenorrhea and FSH > 30 mIU/mL14;
  • Sexually active - women with regular sexual activity and to have penetrative sex with a partner without a history of sexual dysfunction in the last 4 weeks; and
  • Use of oestrogen and progesterone oral or parenteral for over 6 months. This item is to prevent hot flashes and vaginal dryness interference in sexual function.

排除标准

  • were as follows:
  • Women in the menopause transition period and/or with FSH <30 mIU/mL;
  • Sexually inactive;
  • Partner with history of sexual dysfunction, such as erectile dysfunction and/or premature ejaculation;
  • Any other form of sexual dysfunction or any other psychiatric disorder that may affect sexual function;
  • Diagnosis of depression, with a score of > 14 on Beck's Depression Inventory;
  • Use of oestrogen and progesterone oral or parenteral prescribed less than 6 months ago or prescribed for low sexual desire (tibolone);
  • Use of drugs that, according to the examiner's evaluation, may affect sexual function;
  • History of bilateral oophorectomy; and
  • Diagnosed with cancer (breast, cervix, endometrium, ovary, intestines, among others);

结局指标

主要结局

application of questionnaire

时间窗: 1 year

application of questionnaire about sexuality and sexual function

次要结局

  • Body mass index(2 years)
  • Metabolic syndrome(3 years)

研究者

发起方
Faculdade de Ciências Médicas da Santa Casa de São Paulo
申办方类型
Other
责任方
Sponsor

研究点 (2)

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